The Recall Desk
SevereFDA (Devices)·Z-0929-2024·Announced 2024-02-14

BrightView Gamma Camera Detector May Fall and Injure Patients

Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall with potential for serious patient injury (laceration, fracture) to lower limbs if detector falls during operation. Although no injuries have been reported, the agency's Class I classification and risk of significant physical harm to patients meets the Severe criterion.

Plain-English summary

Philips North America is recalling the BrightView gamma camera system due to a component failure that may cause the detector to unexpectedly fall during operation.

The detector arm can fall without warning. If the detector is positioned below the center of the gantry, it could strike a patient's lower limbs, potentially causing abrasion, contusion, laceration, and/or fracture. If the detector is positioned above the center of the gantry, the fall would interrupt normal system operation. This recall affects 302 units distributed domestically in the United States and 264 units distributed internationally. All serial numbers are affected.

Patients and healthcare facilities using BrightView systems should contact Philips North America for repair or replacement instructions. Patients scheduled for imaging should consult their healthcare provider about the status of their facility's equipment.

The recalled product

Product
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
Manufacturer
Philips North America
Hazard
  • detector-fall
  • laceration
  • fracture
  • contusion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers are affected. No UDI-DI available for this product.

Distribution

Distributed nationwide across the United States.